Minimally invasive adjustable support

ABSTRACT

A method of addressing pelvic dysfunction in a patient includes forming an incision; placing an anchor that is attached to a support member by an interconnecting member onto a distal tip of a tool; inserting the distal tip of the tool and the anchor into the incision and guiding the anchor to an obturator foramen; pushing the anchor through a membrane extending over the obturator foramen; and adjusting the support member by sliding the interconnecting member relative to the anchor.

This application is a Continuation-in-Part of prior application Ser. No.12/621,517, filed on Nov. 19, 2009, which prior application was aContinuation-in-Part of prior application Ser. No. 12/414,709, filed onMar. 31, 2009, which claimed the benefit of U.S. Provisional ApplicationNo. 61/150,276, filed on 5 Feb. 2009.

TECHNICAL FIELD

This disclosure relates generally to medical devices. More particularly,this disclosure relates to implantable devices, tools, and methods foranatomical support.

BACKGROUND

Devices for anatomical support, and particularly those for treatment ofurinary incontinence and pelvic organ prolapse have been proposed inrecent years. Such devices have included suburethral sling devices forurinary incontinence, and mesh devices for pelvic organ prolapse. Slingdevices are surgically implanted under a patient's urethra to providesupport to the urethra so that during a provocative event such ascoughing or laughing, urine is inhibited from leaking out of theurethra. Devices for treatment of pelvic organ prolapse are alsosurgically implanted, to inhibit herniation or prolapse of an organ(e.g., the bladder) into the vaginal space. Such support from the slingand mesh devices replaces natural anatomical support that is lacking inthe patient. But implanting and anatomically securing some devices maybe difficult and time consuming. Further, in the case of urinaryincontinence, some sling devices may provide unreliable anatomicalfixation and unacceptable adjustment or tensioning for supporting theurethra, thereby leading to suboptimal or even unacceptable results fortreatment of urinary incontinence.

SUMMARY

This disclosure describes novel implantable devices that provide supportto a urethra or other anatomical structure. This disclosure alsodescribes novel tools and methods for use with the implantable devices.

In one aspect, an implantable device for anatomical support includes asling, a first interconnecting member that is coupled to the sling, anda second interconnecting member that is coupled to the sling. Anadjustable anchor is slidably coupled to the first interconnectingmember to permit bi-directional movement along the first interconnectingmember, and configured to exert a compressive force generatingfrictional interference between the adjustable anchor and the firstinterconnecting member, to inhibit the bi-directional movement of theadjustable anchor along the first interconnecting member unlesssufficient force is applied to overcome the frictional interference.Also, a fixed anchor is fixedly coupled to the second interconnectingmember. In another aspect, the first interconnecting member and thesecond interconnecting member are sutures. In another aspect, the firstinterconnecting member and the second interconnecting member arematerials having an overall width approximating that of a surgicalsuture.

In another aspect, an implantable device for anatomical support includesa sling, a first interconnecting member that is coupled to the sling,and a second interconnecting member that is coupled to the sling. Ananchor is provided in freely sliding engagement with the firstinterconnecting member. A tensioning element is slidably coupled to thefirst interconnecting member to permit movement along the firstinterconnecting member and configured to exert a compressive forcegenerating frictional interference between the tensioning element andthe first interconnecting member, to inhibit the movement of thetensioning element along the first interconnecting member unlesssufficient force is applied to overcome the frictional interference.Also, a fixed anchor is fixedly coupled to the second interconnectingmember. In another aspect, the first interconnecting member and thesecond interconnecting member are sutures. In another aspect, the firstinterconnecting member and the second interconnecting member arematerials having an overall width approximating that of a surgicalsuture.

In another aspect, an implantable device for anatomical support includesan anatomical support member and an interconnecting member that iscoupled to the anatomical support member. An adjustable anchor isslidably coupled to the interconnecting member to permit bi-directionalmovement along the interconnecting member and configured to exert acompressive force generating frictional interference between theadjustable anchor and the interconnecting member, to inhibit thebi-directional movement of the adjustable anchor along theinterconnecting member unless sufficient force is applied to overcomethe frictional interference. In another aspect, the anatomical supportmember is a shaped mesh material for treatment of prolapse. In anotheraspect, the interconnecting member is a suture. In another aspect, theinterconnecting member is a material having an overall widthapproximating that of a surgical suture.

In another aspect, an implantable device for anatomical support includesan anatomical support member, an interconnecting member that is coupledto the anatomical support member, and an anchor in freely slidingengagement with the interconnecting member. A tensioning element isslidably coupled to the interconnecting member to permit movement alongthe interconnecting member and configured to exert a compressive forcegenerating frictional interference between the tensioning element andthe interconnecting member, to inhibit the movement of the tensioningelement along the interconnecting member unless sufficient force isapplied to overcome the frictional interference. In another aspect, theinterconnecting, member is a suture. In another aspect, theinterconnecting member is a material having an overall widthapproximating that of a surgical suture.

In another aspect an adjustable anchor, for use with an anatomicalsupport member having an interconnecting member extending therefrom,includes a body having a proximal end and a distal end, wherein thedistal end includes a flange section that is wider than the proximalend. A collar surrounds, and generates a compressive force against, theproximal end of the body, wherein the interconnecting member is disposedbetween the body and the collar, subject to the compressive force thatgenerates frictional interference to inhibit bi-directional movement ofthe adjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference. In anotheraspect, a plurality of flanges protrude from the flange section,separated by webs. In another aspect, at least one flange has an anglededge. In another aspect, at least one web is self-creasing.

In another aspect an adjustable anchor and a tool, for placing in apatient an anatomical support member having an interconnecting memberextending therefrom, includes an anchor body having a proximal end, adistal end, and a channel extending longitudinally through the anchorbody, wherein the distal end includes a flange section that is widerthan the proximal end. An anchor collar surrounds, and generates acompressive force against, the proximal end of the anchor body, whereinthe interconnecting member is disposed between the anchor body and theanchor collar, subject to the compressive force that generatesfrictional interference to inhibit bi-directional movement of theadjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference. A tool shafthas a proximal end, a shoulder, and a distal tip proximate the shoulder.A helical curve in the shaft terminates at the shoulder. The distal tipis configured to be placed in the channel through the anchor body suchthat the shoulder abuts the anchor body adjacent to the flange section.The helical curve is configured to guide the distal tip from a vaginalincision, around a descending ramus, and through an obturator foramen.In another aspect, a handle is coupled to the proximal end.

In another aspect a surgical method is provided for use with (i) animplantable device having an anatomical support member, a fixed anchorcoupled to the implantable device, an adjustable anchor, and aninterconnecting member that couples the implantable device to theadjustable anchor in frictional sliding engagement, (ii) a first toolcorresponding to a first side of a patient, and (iii) a second toolcorresponding to a second side of a patient. The method includesplacement of the fixed anchor on a distal tip of the first tool. Avaginal incision in the patient is entered with the fixed anchor on thedistal tip of the first tool. The first tool is rotated in a directioncorresponding to the first side of the patient such that the fixedanchor travels in a path around a descending pubic ramus on the firstside of the patient, continuing in the path until the fixed anchor isplaced in obturator tissue on the first side of the patient; and thefirst tool is removed from the patient. An adjustable anchor is placedon a distal tip of the second tool. The vaginal incision in the patientis entered with the adjustable anchor on the distal tip of the secondtool. The second tool is rotated in a direction corresponding to thesecond side of the patient such that the adjustable anchor travels in apath around a descending pubic ramus on the second side of the patient,continuing in the path until the adjustable anchor is placed inobturator tissue on the second side of the patient; and the second toolis removed from the patient. The interconnecting member, in frictionalsliding engagement with the adjustable anchor, is pulled to adjust alength of the interconnecting member between the anatomical supportmember and the adjustable anchor.

In another aspect an implantable anatomical support includes a supportbody and at least three arms extending from the support body, aninterconnecting member that is coupled to one each of at least two ofthe arms extending from the support body, and an adjustable anchorslidably coupled to each of at least two of the interconnecting members.The adjustable anchor is configured to permit bi-directional movementalong the interconnecting member and configured to exert a compressiveforce generating frictional interference between the adjustable anchorand the interconnecting member to inhibit the bi-directional movement ofthe adjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference.

Another aspect provides a method of addressing pelvic dysfunction in apatient. The method includes forming an incision, and placing an anchorthat is attached to a support member by an interconnecting member onto adistal tip of a tool. The method additionally includes inserting thedistal tip of the tool and the anchor into the incision, guiding theanchor to an obturator foramen, and pushing the anchor through amembrane extending over the obturator foramen. The method furtherincludes adjusting the support member by sliding the interconnectingmember relative to the anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of one embodiment of an implantable device foranatomical support.

FIG. 2 is an exploded illustration of a component of the implantabledevice shown in FIG. 1.

FIG. 3 is an exploded illustration of another component of theimplantable device shown in FIG. 1.

FIG. 4 is an assembled, top view of the component shown in FIG. 3.

FIG. 5 is an illustration of the implantable device shown in FIG. 1,after implantation in a patient.

FIG. 6 is an illustration of another embodiment of an implantable devicefor anatomical support.

FIG. 7 is a magnified illustration of components of the implantabledevice shown in FIG. 6.

FIG. 7A is a cross-sectional view of components shown in FIG. 7, takenalong lines 7A-7A.

FIG. 8 is a magnified illustration of one of the components shown inFIG. 6.

FIG. 8A is a top view of the component shown in FIG. 8.

FIG. 9 is a magnified illustration of an alternative component for thedevice shown in FIG. 6.

FIG. 9A is a top view of the component shown in FIG. 9.

FIG. 10A is a partial illustration of another embodiment of animplantable device for anatomical support.

FIG. 10B is an illustration of another embodiment of an implantabledevice for anatomical support.

FIG. 10C is an illustration of another embodiment of an implantabledevice for anatomical support

FIG. 11 is an illustration of one embodiment of a pair of tools for usein a surgical method to place an anatomical support member in a patient.

FIG. 12 is a magnified, partial illustration of one of the tools shownin FIG. 11, coupled to a component shown in FIG. 1.

FIG. 13 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 14 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 15 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 16 is a top view of one embodiment of a system for addressingpelvic dysfunction in a male including an adjustable support member andan introducer tool.

FIG. 17 is a top view of the adjustable support member illustrated inFIG. 16.

FIG. 18A is a side view of the introducer tool illustrated in FIG. 16,and FIG. 18B is a close-up view of a distal tip of the tool.

FIG. 19 is a schematic view of an inside-out insertion path for the toolentering through an incision and piercing an obturator foramen of thepatient for placement of trans obturator arms of the support member.

FIG. 20 is a schematic view of an insertion path for the tool taking anoptional suprapubic approach from the abdomen down to the incision forplacement of suprapubic arms of the support member.

FIG. 21 is a schematic view of one embodiment of the adjustable supportmember illustrated in FIG. 17 as implanted via a single incision.

FIG. 22A is a perspective view of one embodiment of a support memberincluding an adjustable anchor and a hanger.

FIG. 22B is a side view and FIG. 22C is a front view of the hangerillustrated in FIG. 22A.

FIG. 23 is a schematic view of one embodiment of the support memberillustrated in FIG. 22 implanted via a single incision with theadjustable anchor inserted in a membrane of an obturator foramen and thehanger secured over a portion of a ramus to allow the support member toalleviate pelvic dysfunction.

FIG. 24 is a top view of one embodiment of a support member includingadjustable anchors and hangers and implantable via a single incision.

FIG. 25 is a schematic view of one embodiment of the adjustable anchorsof FIG. 24 anchored to membranes of obturator foramen and the hangerssecured to the pelvis.

FIG. 26 is a schematic view of a pair of adjustable supports asillustrated in FIG. 1 implanted into a patient via a single incision toalleviate pelvic dysfunction.

DETAILED DESCRIPTION

One embodiment of an implantable device for anatomical support (device10) is illustrated in FIG. 1. Therein, an anatomical support member in aform of a suburethral sling includes anchors that are deployed into apatient's tissues. The anchors are coupled to the sling byinterconnecting members. In this regard a fixed anchor is fixedlyconnected in fixed relation to the sling by a first interconnectingmember, and an adjustable anchor is slidably coupled in adjustablerelation to the sling by a second interconnecting member. The adjustableanchor, as will be described, is configured to permit bi-directionalmovement along the second interconnecting member in frictional slidingengagement therewith. In one embodiment, the interconnecting members arelengths of suture or suture-like material.

With particular reference to FIGS. 1 and 2, an example of device 10includes a suburethral sling 100 with opposing ends 102 and 104. Device10 also includes interconnecting member 110 having opposing ends 112 and114, and interconnecting member 129 having opposing ends 130 and 134.End 112 of interconnecting member 110 is coupled to end 102 of sling100; and as shown in FIG. 2 end 130 of interconnecting member 129 iscoupled to end 104 of sling 100. Although shown in the drawings viaphantom lines as being coupled to an underside or bottom surface ofsling 100, it is to be understood that the coupling of interconnectingmembers 110 and 129 to sling 100 may be provided at any suitable surfaceof sling 100 and at any suitable orientation thereon.

Also as shown in FIG. 2, in one embodiment device 10 includes a fixedanchor 136 having a body 122 with a proximal end and a distal end, and achannel 124 extending longitudinally therethrough. A plurality offlanges 126 protrude from the distal end, separated by webs 127. End 134of interconnecting member 129 is fixedly coupled to body 122. Fixedanchor 136 also includes a collar 138. When assembled for use in device10 as shown in FIG. 1, collar 138 covers the proximal end of body 122 offixed anchor 136 and end 134 of interconnecting member 129 coupled tobody 122.

Device 10 also includes an adjustable anchor 120. Referring to FIGS. 3and 4, in one embodiment adjustable anchor 120 includes a body 122having a proximal end and a distal end, with a channel 124 extendinglongitudinally therethrough and a plurality of flanges 126 protrudingfrom the distal end that are in turn separated by webs 127. As shown inFIG. 3 in exploded half-section, and in a top assembly view in FIG. 4,adjustable anchor 120 has a collar 128 surrounding the proximal end thatincludes a pair of apertures 128A and 128B. When assembled for use indevice 10, collar 128 covers body 122 of adjustable anchor 120 whileapertures 128A-B in collar 128 permit passage of interconnecting member110 therethrough in frictional sliding engagement with adjustable anchor120. In this regard and with reference to FIG. 4, it is to beappreciated and understood that interconnecting member 110 is disposedthrough aperture 128A of collar 128, around a partial circumference ofbody 122, and through aperture 128B of collar 128. By virtue of anintentionally close fit to exert a compressive force and thus frictionalinterference between interconnecting member 110, collar 128, and body122, adjustable anchor 120 is slidably coupled to interconnecting member110 to permit bi-directional movement along interconnecting member 110upon overcoming such frictional interference.

It is to be understood that an amount of compressive force and thusdesired frictional interference could be varied among embodiments ofadjustable anchor 120 with regard to an elasticity of a particularmaterial chosen for collar 128 and also with regard to placement ofapertures 128A and 128B in collar 128. For example, with locations ofapertures 128A-B being constant, if a material chosen for collar 128 ina first embodiment of adjustable anchor 120 has less elasticity than amaterial chosen for collar 128 in a second embodiment of adjustableanchor 120, then the compressive force and resulting frictionalinterference of the first embodiment would be greater than that of thesecond embodiment due to, comparatively, greater resistance of collar128 against interconnecting member 110 in the first embodiment than inthe second embodiment. Similarly, with a material for collar 128 beingconstant, if apertures 128A-B are placed farther apart in one embodimentof anchor 120 than in a second embodiment of anchor 120, then thecompressive force and resulting frictional interference of the firstembodiment would be greater than that of the second embodiment due to,comparatively, a longer path through adjustable anchor 120 ofinterconnecting member 110 in the first embodiment than in the secondembodiment.

This feature of frictional sliding engagement between interconnectingmember 110 and adjustable anchor 120 enables adjustment and tensioningof sling 100 when implanted in a patient. Referring to FIG. 5, oneembodiment of device 10 is illustrated as having been implanted in apelvic region P of a patient that includes urethra U and obturatortissue OT in each obturator foramen OF. In the drawing suburethral sling100 of device 10 is shown as having been positioned under the patient'surethra U, with placement of fixed anchor 136 in obturator tissue OT ofone obturator foramen OF and placement of adjustable anchor 120 inobturator tissue OT in the other obturator foramen OF. If desired,positions of anchors 120 and 136 could be exchanged in a left and rightsense relative to pelvic region P. As will be further described, flanges126 and webs 127 of anchors 120 and 136 secure the placement of eachanchor in respective obturator tissue OT; and in one embodiment, atleast one flange 126 has an angled or beveled edge 126E to promote suchsecure placement in obturator tissue OT or other anatomical tissue.

In one embodiment, at least one web 127 is self-creasing. Specifically,upon application of pressure to flange 126 such as when anchors 120 and136 are being deployed through and secured at selected anatomicaltissue, web 127 tends to fold or crease which thereby tends tofacilitate, advantageously, a temporary bending or deflection of anadjacent flange 126 downwardly and inwardly toward longitudinal channel124. In turn, this downward or inward bending or deflection of flange126 tends to facilitate such deployment of the anchor through and intothe tissue. Furthermore, upon such deployment through tissue, web 127advantageously tends to inhibit an inverse bending or deflection offlange 126 upwardly toward body 122.

By way of the coupling of interconnecting members 110 and 129 to anchors120 and 136 respectively, and the coupling of interconnecting members110 and 129 to ends 102 and 104 of sling 100 respectively, sling 100 ismaintained in position as desired under urethra U. With fixed anchor 136and adjustable anchor 120 so implanted in obturator tissue OT, and withregard to the frictional sliding engagement between interconnectingmember 110 and adjustable anchor 120, it is to be particularlyunderstood that pulling on end 114 of interconnecting member 110 awayfrom adjustable anchor 120 with a force sufficient to overcome theaforementioned interference force between interconnecting member 110 andadjustable anchor 120 would cause interconnecting member 110 to passthrough anchor 120 with a resultant shortening of a distance between end102 of sling 100 and adjustable anchor 120. Thereby, sling 100 would beraised or elevated under urethra U as may be desired and as will befurther described. Conversely, pulling on end 112 of interconnectingmember 110 away from adjustable anchor 120 (or pulling on sling 100 awayfrom anchor 120, or so pulling on both end 112 and sling 100) with suchforce would overcome the interference and cause interconnecting member110 to pass in an opposite direction through anchor 120 with a resultantlengthening of a distance between end 102 of sling 100 and adjustableanchor 120. Thereby, sling 100 would be lowered under urethra U as maybe desired and as will be further described.

It is to be appreciated and understood that the novel construction andoperation of device 10 is to be provided with respect to three forceparameters. First, device 10 is to be constructed such that adjustableanchor 120 is not destroyed or otherwise damaged upon frictional slidingmovement of interconnecting member 110 through anchor 120. Second,device 10 is to be constructed such that neither fixed anchor 136 nor,particularly, adjustable anchor 120 are pulled out or dislodged fromobturator tissue OT into which they have been placed and secured, uponmovement of interconnecting member 110 through adjustable anchor 120during intraoperative adjustment. Third, device 10 is to be constructedsuch that the aforementioned interference force between interconnectingmember 110 and adjustable anchor 120 is sufficiently high to inhibitmovement of sling 100 under urethra U during a provocative event such ascoughing by the patient when internal anatomical forces are exerted upondevice 10.

In one embodiment, sling 100 has a length of about 7 cm (2.76 in.) and awidth in a range of about of 8 mm (0.315 in.) to 11 mm (0.433 in.).Further, in one embodiment sling 100 is a medical grade material suchas, for example, knitted polypropylene ARIS® brand mesh material that iscommercially available from Coloplast A/S; and interconnecting members110 and 129 are lengths of medical grade suture or suture-like materialsas aforementioned. In another embodiment, interconnecting members 110and 129 could be, for example, the aforementioned polypropylene materialof sling 100 that has been knitted, woven, or otherwise formed into anelongated suture-like filamentary material. In another embodimentinterconnecting members 110 and 129 could be, variously alone ortogether, continuations of the material of sling 100 configured to havecharacteristics of a suture-like filamentary material. Accordingly, suchembodiments would provide a material having an overall widthapproximating that of a surgical suture.

Anchors 120 and 136 could be manufactured using any suitable materialssuch as polypropylene and polyurethane, and fabrication techniques suchas molding and milling. In one embodiment, body 122, flanges 126, andwebs 127 are fabricated from polypropylene. In one embodiment, collar128 is molded from a thermoplastic polyurethane material or polymericelastomer such as TECOTHANE® brand material. In one embodiment, anchors120 and 136 have an overall length of 0.622 cm (0.245 in.) and a maximumwidth at flanges 126 of 0.470 cm (0.185 in.). In one embodiment, flanges126 have a width of 0.114 cm (0.045 in.) and a thickness of 0.038 cm(0.015 in.). In one embodiment, webs 127 have a thickness ofapproximately one-half that of flanges 126, or about 0.019 cm (0.008in.). In one embodiment, body 122 has a length of 0.312 cm (0.123 in.)and a diameter of 0.172 cm (0.068 in.). In one embodiment, longitudinalchannel 124 in body 122 has a diameter of 0.097 cm (0.038 in.). In oneembodiment, before being assembled as described below, collar 128 has aninner diameter of 0.127 cm (0.050 in.), an outer diameter of 0.254 cm(0.100 in.), and a length of 0.318 cm (0.125 in.); and apertures 128A-Bhave a diameter of 0.051 cm (0.020 in.). In one embodiment, collar 138of anchor 136 has an inner diameter of 0.191 cm (0.075 in.), an outerdiameter of 0.254 cm (0.100 in.), and a length of 0.254 cm (0.100 in.).

In one example of construction of device 10, with reference again toFIG. 2, end 112 of interconnecting member 110 is sonically welded to end102 of sling 100; and end 134 of interconnecting member 129 is sonicallywelded to end 104 of sling 100. Further in this example, end 134 ofinterconnecting member 129 is placed against body 122 of anchor 136, andcollar 138 is placed over body 122 and end 134. Those assembledcomponents are then sonically welded, thereby securing interconnectingmember 129 to anchor 136.

Regarding assembly of adjustable anchor 120, in one embodiment collar128 is swelled by using a suitable solvent such as methylethylketone (orMEK; also referred to as butanone). Collar 128, manufactured from thethermoplastic polyurethane material as aforementioned, is immersed inthe MEK for approximately four hours whereupon it swells or becomesenlarged due to infiltration of the MEK into a molecular composition ofthe polyurethane material causing its expansion in all dimensions.Swelled collar 128 is then loosely placed over body 122 of adjustableanchor 120, and as aforementioned end 114 of interconnecting member 110is then passed through aperture 128A of collar 128, around a partialcircumference of body 122, and through aperture 128B such that a segmentof interconnecting member 110 is within apertures 128A-B. In anotherembodiment interconnecting member 110 is placed through apertures 128Aand 128B of swelled collar 128 such that a segment of interconnectingmember 110 is within apertures 128A-B, and then collar 128 is placedover body 122 of adjustable anchor 120. That assembly is then raised toa temperature of 30 C for approximately 24 hours, to accelerateevaporation of the MEK from the thermoplastic polyurethane material.When the MEK evaporates, the swelling of collar 128 decreases,effectively returning collar 128 to its pre-swelled dimensions. Thereby,collar 128 tightly surrounds body 122 and interconnecting member 110disposed therebetween. A result of such assembly is that interconnectingmember 110 is movable through apertures 128A-B of collar 128, infrictional sliding contact between body 122 and an inside surface ofcollar 128.

Although a path through apertures 128A-B is illustrated as beingperpendicular to longitudinal channel 124, one aperture 128A or 128Bcould be at a higher or lower point on collar 128 than the otheraperture and thus the path through apertures 128A-B could be at anotherangle relative to channel 124.

Also, it is to be understood that the aforedescribed connections ofcomponents by sonic welding could instead be accomplished by any othersuitable means such as, for example, by use of a suitable adhesivematerial.

In another embodiment, anchor 136 could be coupled directly toanatomical support member 100. In such an embodiment, interconnectingmember 129 could be omitted and end 104 could be, for example, sonicallywelded, glued, or otherwise mechanically coupled to anchor 136 betweenan outside surface of body 122 and an inside surface of collar 128. Inanother embodiment, collar 128 could be omitted with, simply, connectionof end 104 to body 122.

Illustrated in FIG. 6 is another example of an implantable device foranatomical support (device 50). In the drawings, like reference numeralsdenote like components among embodiments. Example device 50 includes ananatomical support member as a suburethral sling 100 with ends 102 and104; interconnecting member 110 with ends 112 and 114; andinterconnecting member 129 with ends 130 and 134. End 112 ofinterconnecting member 110 is coupled to end 102 of sling 100; and end130 of interconnecting member 129 is fixedly coupled to end 104 of sling100. Although shown in the drawings via phantom lines as being coupledto an underside or bottom surface of sling 100, it is to be understoodthat the coupling of interconnecting members 110 and 129 to sling 100may be provided at any suitable surface of sling 100 and at any suitableorientation thereon.

Fixed anchor 136 includes a body 122 having a proximal end and a distalend, with a longitudinal channel 124 extending therethrough. A pluralityof flanges 126 protruding from the distal end of body 122, separated bywebs 127. End 134 of interconnecting member 129 is fixedly coupled tobody 122 of fixed anchor 136; and fixed anchor 136 includes a collar138. Collar 138 covers the proximal end of body 122 and end 134 ofinterconnecting member 129 coupled to body 122.

Referring to FIGS. 7, 8 and 8A, device 50 also includes an anchor 520and a separate tensioning element 530 slidably coupled tointerconnecting member 110. In one embodiment, anchor 520 includes abody 522 having a channel 526 extending longitudinally therethrough, anda plurality of flanges 524 protruding therefrom separated by webs 527;and in one embodiment, at least one flange 524 has an angled or bevelededge 524E to promote secure placement in obturator tissue OT or otheranatomical tissue.

In one embodiment, at least one web 527 is self-creasing. Specifically,upon application of pressure to flange 524 such as when anchor 520 isbeing deployed through and secured at selected anatomical tissue, web527 tends to fold or crease which thereby tends to facilitate,advantageously, a temporary bending or deflection of an adjacent flange524 downwardly and inwardly toward longitudinal channel 526. In turn,this downward or inward bending or deflection of flange 524 tends tofacilitate such deployment of the anchor through and into the tissue.Furthermore, upon such deployment through tissue, web 527 advantageouslytends to inhibit an inverse bending or deflection of flange 524 upwardlytoward body 522.

Anchor 520 also has a channel 528 through body 522 to permitinterconnecting member 110 to move therethrough in freely slidingengagement with anchor 520. In this example of device 50, and referringto FIGS. 6, 7, and 7A, interconnecting member 110 is partially disposedwithin tensioning element 530. In one embodiment, tensioning element 530is fabricated from a suitable biocompatible material such as, e.g.,silicone or a low durometer thermoplastic material like polyurethane. Inassembly of device 50, ends 112 and 114 of interconnecting member 110are disposed within tensioning element 530 (indicated by paths 532 inFIG. 7). In particular, although not illustrated, it is to be understoodthat in one embodiment end 114 of interconnecting member 110 is driventhrough tensioning element 530 by use of, e.g., a needle. End 114 isthen placed through channel 528 of anchor 520 and then driven by theneedle back through tensioning element 530. As shown in FIG. 7A, byvirtue of exertion of a compressive force and thus frictionalinterference between tensioning element 530 and interconnecting member110, tensioning element 530 is slidably coupled to interconnectingmember 110 to permit bi-directional movement along interconnectingmember 110 upon overcoming such frictional interference. This feature ofsliding frictional interference between interconnecting member 110 andtensioning element 530 permits adjustment and tensioning of sling 100when implanted in a patient. With reference to FIG. 5, it is to beunderstood that device 50 could be substituted for device 10 andimplanted in a pelvic region P of a patient that includes urethra U andobturator tissue OT in each obturator foramen OF. Thus, suburethralsling 100 of device 50 could be positioned under the patient's urethraU, with secure placement of fixed anchor 136 in obturator tissue OT ofone obturator foramen OF and by secure placement of anchor 520 inobturator tissue OT in the other obturator foramen OF. Positions ofanchors 520 and 136 could be exchanged in a left and right senserelative to pelvic region P. By grasping tensioning element 530 andpulling on end 114 away from tensioning element 530 with a forcesufficient to overcome the aforementioned frictional interference forcebetween interconnecting member 110 and tensioning element 530,interconnecting member 110 slides through tensioning element 530 andthus through anchor 520 with a resultant shortening of a distancebetween end 102 of sling 100 and tensioning element 530. Thereby, sling100 would be raised or elevated under urethra U. Conversely, graspingtensioning element 530 and pulling on end 112 of interconnecting member110 away from tensioning element 530 (or pulling on sling 100 away fromtensioning element 530, or so pulling on both end 112 and sling 100)with such force would overcome the interference and causeinterconnecting member 110 to pass through tensioning element 530 andthus in an opposite direction through tensioning element 530 with aresultant lengthening of a distance between end 102 of sling 100 andtensioning element 530. Thereby, sling 100 would be lowered underurethra U.

Like device 10, it is to be appreciated and understood that the novelconstruction and operation of device 50 is to be provided with respectto three force parameters. First, device 50 is to be constructed suchthat tensioning element 530 is not destroyed or otherwise damaged uponfrictional sliding movement of interconnecting member 110 through it.Second, device 50 is to be constructed such that neither anchor 136 noranchor 520 are pulled out or dislodged from obturator tissue OT intowhich they have been placed and secured, upon of movement ofinterconnecting member 110 through tensioning element 530 duringintraoperative adjustment. Third, device 50 is to be constructed suchthat the aforementioned interference force between interconnectingmember 110 and tensioning element 530 is sufficiently high to inhibitmovement of sling 100 under urethra U during a provocative event whenthe patient's internal anatomical structures or tissues exert forcesupon device 50.

In one embodiment of device 50, components of anchor 520 could beconstructed in dimensions, and from materials and techniques, asvariously described regarding similar components of fixed anchor 136 indevice 10. Furthermore, components of one embodiment of device 50 couldbe coupled and secured as described relative to similar components ofdevice 10.

Another embodiment of anchor 520 is depicted in FIGS. 9 and 9A whereinchannel 526 is a generally semi-circular or “D” shape. D-shaped channel526, extending longitudinally through body 522, could provide moreclearance for channel 528 compared to the longitudinal and fullycylindrical channel 526 shown in FIGS. 7, 8 and 8A. Furthermore, andalthough not illustrated, longitudinal channel 526 could also beprovided in a smaller diameter than as shown in FIGS. 8A and 9A tothereby provide even greater clearance for channel 528. A path throughchannel 528 is illustrated as being perpendicular to longitudinalchannel 526; but in another embodiment, the path could be at anotherangle relative to channel 526.

It is to be appreciated that when implanted in a patient, sling 100 ofdevices 10 and 50 advantageously extends nearly from obturator tissue OTon one side of the patient to obturator tissue OT on an opposite side ofthe patient as a result of, e.g., an intentionally short segment ofinterconnecting member 129 that couples end 104 of sling 100 to fixedanchor 136 and a selected length of sling 100 with respect to a typicaldistance between opposing obturator foramen OF.

Referring to FIG. 10A, and with additional reference to FIGS. 1, 3, and4, it is to be appreciated that the novel adjustable anchor 120described herein could be useful for secure placement of virtually anyanatomical support member (A) coupled to an interconnecting member 110where it is desired to provide adjustment or tensioning of the supportmember when implanted in a patient. Anatomical support member (A) couldbe, for example, a shaped mesh material for treatment of prolapse. Also,an anatomical support member could employ any number of adjustableanchors 120, with or without any number of fixed anchors 136.

Referring to FIGS. 10B and 10C, it is to be also appreciated that thenovel adjustable anchor 120 described herein could be useful with animplantable device (S) for treatment of urinary incontinence where it isdesired to provide adjustment or tensioning of device (S) when implantedin a patient. Although not specifically depicted in FIGS. 10B-C, it isto be understood however that device (S) could employ any number ofadjustable anchors 120, with or without any number of fixed anchors 136.

Although not illustrated in FIGS. 10A-C, it is to be understood thatanchor 520 with tensioning element 530 could be utilized with anyanatomical support member (A); and any number of combinations of anchor520 with tensioning element 530 could also be utilized with or withoutany number of fixed anchors 136.

Regardless of a particular embodiment of adjustable anchor 120, or ofanchor 520 with tensioning element 530, it is to be understood andappreciated that such novel anchors described herein may be relativelysmall when compared to known anatomical anchors. This advantage resultsfrom the fact that the novel anchors described herein are coupled toanatomical support members by sutures or suture-like filaments, ratherthan directly to the anatomical support members themselves which areusually larger and wider than sutures or suture-like filaments as insome known anatomical anchors. In alternative embodiments, any of theanchors (e.g., anchors 120, 136, or 520) would include at least oneflange 126.

FIGS. 11 and 12 illustrate an example of a tool for use in placing animplantable device for anatomical support in a patient, such as sling100 of FIG. 1. In the drawing, a pair of tools 600R and 600L areillustrated, in left hand and right hand embodiments—with suchdesignations referring to a patient's left and right sides,respectively. It is to be understood that the tools are identical exceptfor a direction of a helical curve C as described below.

In this example, tools 600R and 600L each include a shaft 610 having aproximal end 612 and a cylindrical distal tip 618. A handle 620 iscoupled to proximal end 612 of shaft 610. Handle 620 could have anydesired shape or configuration with respect to ergonomic and otherconsiderations of interest. A generally helical curve C is provided inshaft 610. Helical curve C terminates in a shoulder 616 proximate todistal tip 618. In use as described below, helical curve C isadvantageously configured to guide tip 618 from an incision (e.g., avaginal incision in a female patient or a perineal incision in a malepatient), around a descending ramus, and through an obturator foramen OFin the patient. In this example; and as shown in FIG. 12, cylindricaldistal tip 618 is configured to be placed through cylindrical channels124 of adjustable anchor 120 and fixed anchor 136 (as shown in, e.g., inFIGS. 2 and 3), and through cylindrical channel 526 of anchor 520 (asshown, e.g., in FIGS. 7, 8, and 8A). When so placed, shoulder 616 abutsthe anchor's body adjacent to the flanges with the anchor being therebycarried on tip 618 of tool 600R or 600L. Although not illustrated, it isto be understood that if an anchor was constructed with a semi-circularor “D” shaped channel 526 as depicted in FIGS. 9 and 9A, tip 618 wouldthen be a complementary semi-circular or “D” shaped configuration.

In one embodiment, handle 620 has a length of 11.43 cm (4.5 in.). Alength of shaft 610, from handle 620 to a beginning point 614 of curve Cis 17.78 cm (7.0 in.). Shaft 610 has a diameter of 3 mm (0.12 in.)decreasing to 1 mm (0.04 in.) at shoulder portion 616. Curve C has aradius of curvature in a range of 2.03 cm (0.80 in.) to 2.54 cm (1.0in.). Suitable materials for construction of handle 620 include, forexample, a medical grade thermoplastic or thermoset material, preferablyhaving both high and low durometer regions for ergonomic considerations.A suitable material for construction of shaft 610 is, for example,medical grade stainless steel. Furthermore, the tool describedherein—such as the examples of tools 600R and 600L—could be disposableor sterilizable and reusable.

It is to be appreciated that in one embodiment, as shown particularly inFIG. 12, a length of distal tip 618 is chosen so that it protrudes froman anchor seated on shoulder 616. When constructed from stainless steelas aforementioned, relatively stiff tip 618 is thereby configured topierce anatomical tissue when in use as described below. Thereby, theanchor itself does not need to include such a tissue-penetrating tip.

Referring in particular to FIGS. 1, 5, 11, and 12, an example of asurgical method to implant a device for anatomical support 10, in a formof suburethral sling 100 for treatment of urinary incontinence in afemale patient, is as follows.

A catheter is placed in the patient's urethra U, among other usual andpreliminary steps in preparation for surgery. The patient is placed onan operating table in a slightly exaggerated lithotomy position withbuttocks extending just beyond an edge of the table. With the patientunder anesthesia, a vaginal incision and blunt dissection are made. Inone embodiment of the method, a fixed anchor is first placed inobturator tissue OT on the patient's left side, followed by placement ofan adjustable anchor in obturator tissue OT on the patient's right side.Accordingly in this embodiment, fixed anchor 136 is placed on distal tip618 of left hand tool 600L having an orientation of helical curve Ccorresponding to the patient's left side. Tip 618 of left hand tool600L, with fixed anchor 136 seated thereupon, is placed within thevaginal incision. Left hand tool 600L is then rotated such that rotationof helical curve C advances tip 618 and fixed anchor 136 in a patharound a descending pubic ramus (PR) on the patient's left side,continuing in that path until fixed anchor 136 penetrates obturatortissue OT on the patient's left side (as may be indicated by an audibleor tactile “pop”) and is thus secured therein. By virtue of flanges 126,fixed anchor 136 is inhibited from being pulled back through obturatortissue OT so penetrated as shown in FIG. 5. Left hand tool 600L is thenremoved from the patient. Next in this embodiment, adjustable anchor 120is placed on distal tip 618 of right hand tool 600R having anorientation of helical curve C corresponding to the patient's rightside. Tip 618 of right hand tool 600R, with adjustable anchor 120seated, thereupon, is placed within the vaginal incision. Right handtool 600R is then rotated such that rotation of helical curve C advancestip 618 and adjustable anchor 120 in a path around a descending pubicramus (PR) on the patient's right side, continuing in that path untiladjustable anchor 120 penetrates obturator tissue OT on the patient'sright side (as may be indicated by an audible or tactile “pop”) and isthus secured therein. By virtue of flanges 126, adjustable anchor 120 isinhibited from being pulled back through obturator tissue OT sopenetrated as shown in FIG. 5. Right hand tool 600R is then removed fromthe patient.

With suburethral sling 100 thus placed and secured in the patient by wayof fixed anchor 136 and adjustable anchor 120, an assessment is made ofwhether sling 100 is unacceptably loose or tight under urethra U. Ifsling 100 is unacceptably loose, then end 114 of interconnecting member110 is pulled away from adjustable anchor 120 with a force sufficient toovercome the aforementioned interference force between interconnectingmember 110 and adjustable anchor 120. Interconnecting member 110 thuspasses through anchor 120 with a resultant shortening of a distancebetween end 102 of sling 100 and adjustable anchor 120. Thereby sling100 is raised or elevated under urethra U as desired. Conversely, ifsling 100 is unacceptably tight, then end 112 of interconnecting member110 is pulled away from adjustable anchor 120 (or sling 100 is pulledaway from adjustable anchor 120, or both end 112 and sling 100 are sopulled) with a force sufficient to overcome the interference forcebetween interconnecting member 110 and adjustable anchor 120.Interconnecting member 110 thus passes through anchor 120 with aresultant lengthening of a distance between end 102 of sling 100 andadjustable anchor 120. Thereby sling 100 is lowered under urethra U asdesired. These steps of shortening and lengthening a distance betweenend 102 of sling 100 and adjustable anchor 120 may be repeated in anyorder and as frequently as necessary to provide optimal suburethralsupport from sling 100 to urethra U. The vaginal incision is then closedand usual post-operative procedures are performed.

In another embodiment, the aforedescribed method could employ an exampleof device 50 as shown in FIGS. 6-8A. In this embodiment of the method, acatheter is placed in the patient's urethra U and the aforementionedpreliminary steps in preparation for surgery are performed. The patientis placed in a slightly exaggerated lithotomy position with buttocksextending just beyond an edge of an operating table; and underanesthesia, a vaginal incision and blunt dissection are made in thepatient. In one embodiment of this method using device 50, a fixedanchor is first placed in obturator tissue OT on the patient's leftside, followed by placement of an anchor in obturator tissue OT on thepatient's right side that is associated with a separate tensioningelement. Accordingly, fixed anchor 136 is placed on distal tip 618 ofleft hand tool 600L having an orientation of helical curve Ccorresponding to the patient's left side. Tip 618 of left hand tool600L, with fixed anchor 136 seated thereupon, is placed within thevaginal incision. Left hand tool 600L is then rotated such that rotationof helical curve C advances tip 618 and fixed anchor 136 in a patharound a descending pubic ramus (PR) on the patient's left side,continuing in that path until fixed anchor 136 penetrates obturatortissue OT on the patient's left side (as may be indicated by an audibleor tactile “pop”) and is thus secured therein. By virtue of flanges 126,fixed anchor 136 is inhibited from being pulled back through obturatortissue OT so penetrated as shown in FIG. 5. Left hand tool 600L is thenremoved from the patient. Next in this embodiment using device 50,anchor 520 is placed on distal tip 618 of right hand tool 600R having anorientation of helical curve C corresponding to the patient's rightside. Tip 618 of right hand tool 600R, with anchor 520 seated thereupon,is placed within the vaginal incision. Right hand tool 600R is thenrotated such that rotation of helical curve C advances tip 618 andanchor 520 in a path around a descending pubic ramus (PR) on thepatient's right side, continuing in that path until anchor 520penetrates obturator tissue OT on the patient's right side (as may beindicated by an audible or tactile “pop”) and is thus secured therein.By virtue of flanges 126, anchor 520 is inhibited from being pulled backthrough obturator tissue OT so penetrated. Right hand tool 600R is thenremoved from the patient.

With suburethral sling 100 of device 50 thus placed and secured in thepatient by way of fixed anchor 136 and anchor 520, an assessment is madeof whether sling 100 is unacceptably loose or tight under urethra U. Ifsling 100 is unacceptably loose, then tensioning element 530 is graspedand end 114 of interconnecting member 110 is pulled away from tensioningelement 530 with a force sufficient to overcome the aforementionedinterference force between interconnecting member 110 and tensioningelement 530. Interconnecting member 110 thus passes through anchor 520with a resultant shortening of a distance between end 102 of sling 100and tensioning element 530. Thereby sling 100 is raised or elevatedunder urethra U as desired. Conversely, if sling 100 is unacceptablytight, then tensioning element 530 is grasped and end 112 ofinterconnecting member 110 is pulled away from tensioning element 530(or sling 100 is pulled away from tensioning element 530, or both end112 and sling 100 are so pulled) with a force sufficient to overcome theinterference force between interconnecting member 110 and tensioningelement 530. Interconnecting member 110 thus passes through anchor 120with a resultant lengthening of a distance between end 102 of sling 100and tensioning element 530. Thereby sling 100 is lowered under urethra Uas desired. Similarly to device 10, these steps of shortening andlengthening a distance between end 102 of sling 100 and tensioningelement 530 in device 50 may be repeated in any order and as frequentlyas necessary to provide optimal suburethral support from sling 100 tourethra U. The vaginal incision is then closed and usual post-operativeprocedures are performed.

The adjustable anchor 120 and/or the fixed anchor 136 are each suitedfor attachment to support devices having a variety of shapes, includingthe rectangular shapes described and illustrated above, non-rectangularshapes described and illustrated below, or other symmetrical ornon-symmetrical shapes as appropriate for providing anatomical support.

FIG. 13 is a top view of one embodiment of an implantable anatomicalsupport 700 device. The implantable anatomical support 700 includes asupport body 702 with at least three arms 704 extending from the supportbody 702, an interconnecting member 110 that is coupled to each of thearms 704 extending from the support body 702, and an adjustable anchor120 slidably coupled to each of at least two of the interconnectingmembers 110.

The adjustable anchors 120 are configured for bi-directional movementalong the interconnecting member 110 and exert a compressive forcegenerating frictional interference between the adjustable anchor 120 andthe interconnecting member 110. The frictional interference between theadjustable anchor. 120 and the interconnecting member 110 inhibits thebi-directional movement of the adjustable anchor 120 along theinterconnecting member 110 unless sufficient force is applied toovercome the frictional interference.

The arms 704 in combination with the interconnecting members 110 and theadjustable anchors 120 allow the anatomical support 700 to be implantedin a body and adjusted into a desired tensioned position. Theinterconnecting members 110 and the adjustable anchors 120 obviate theuse of multiple skin exit punctures, and eliminate the use of retrievercomponents and sleeves around the arms 704 that are at times employedwith support bodies having arms.

The support body 702 is non-rectangular and the support 700 includesfour arms 704 extending from the non-rectangular support body 702. Inone embodiment, the support body 702 has a curved outside perimeter withbilateral symmetry relative to a central longitudinal axis of thenon-rectangular support body 702. In one embodiment, the support body702 has four arms 704 and includes a central tail 706 located betweentwo of the arms 704. The central tail is configured for attachment to asuitable pelvic landmark, such as a ligament or other tissue. In oneembodiment, the support body 702 is fabricated from a porous meshconfigured to be compatible with biological in-situ tissue ingrowth.

In one embodiment, the arms 704 include a first arm segment 710extending from support body 702 and a second arm segment 712 extendingfrom the first arm segment 710, where the interconnecting members 110extend from the second arm segment 712.

In one embodiment, the second arm segment 712 is the removed end portion104 of the sling 100 described above and is attached to body 702. In oneembodiment, the second arm segment 712 is fabricated from the knittedpolypropylene material described above and is attached to the first armsegment 710 and the support body 702. In one embodiment, the first armsegment 710 is fabricated from a different material than the second armsegment 712. Suitable attachment methods for attaching the second armsegment 712 to the first arm segment 710 include adhesive attachment,mechanical attachment devices such as clips, and energetic attachmentssuch as sonic or ultrasonic welds, as examples.

In one embodiment, the first arm segment 710 is fabricated from the samematerial as the second arm segment 712. For example, each of the firstarm segment 710 and the second arm segment 712 is fabricated fromknitted polypropylene ARIS® brand mesh material that is commerciallyavailable from Coloplast A/S.

In one embodiment, the first arm segments 710 extend 1 cm or more fromthe support body 702. In one embodiment, one or more of the first armsegments 710 is provided as a “stubby” arm segment that extends from thesupport body 702 by less than 1 cm, for example. The second arm segment712 extends from the first arm segment 710 (whether of the “stubby”format or not). The interconnecting member 110 is attached to the secondarm segment 712, and one or the other of the adjustable anchor 120 orthe fixed anchor 136 is attached to the interconnecting member 110.

In one embodiment, an interconnecting member 110 is attached to each arm704 and an adjustable anchor 120 is attached to each interconnectingmember 110. In one embodiment, an interconnecting member 110 is attachedto each arm 704 and a fixed anchor 136 (FIG. 1) is attached to at leastone of the interconnecting members 110. It will be recognized that theimplantable anatomical support 700 could include one or more adjustableanchors with anywhere from zero to one or more fixed anchors. It is tobe appreciated, then, that the device 700 could employ any number ofadjustable anchors 120, with or without any number of fixed anchors 136.

FIG. 14 is a top view of one embodiment of an implantable anatomicalsupport 800. The implantable anatomical support 800 includes a supportbody 802 with at least three arms 804 extending from the support body802, an interconnecting member 110 that is coupled to the arms 804extending from the support body 802, and an adjustable anchor 120slidably coupled to each of at least two of the interconnecting members110.

The adjustable anchors 120 are configured for bi-directional movementalong the interconnecting member 110 and exert a compressive forcegenerating frictional interference between the adjustable anchor 120 andthe interconnecting member 110. The frictional interference between theadjustable anchor 120 and the interconnecting member 110 inhibits thebi-directional movement of the adjustable anchor 120 along theinterconnecting member 110 unless sufficient force is applied toovercome the frictional interference.

The arms 804 in combination with the interconnecting members 110 and theadjustable anchors 120 allow the anatomical support 800 to be implantedin a body and adjusted into a desired tensioned position. Theinterconnecting members 110 and the adjustable anchors 120 obviate theuse of multiple skin exit puncture, and eliminate the use of retrievercomponents and sleeves around the arms 804 that are at times employedwith support bodies having arms.

The support body 802 is non-rectangular and the support 800 includes twoarms 804 a, 804 b extending from one side of the non-rectangular supportbody 802 and a third arm 804 c that is provided opposite the two arms804 a, 804 b. In one embodiment, the support body 802 has a curvedoutside perimeter with bilateral symmetry relative to a centrallongitudinal axis of the non-rectangular support body 802. In oneembodiment, the support body 802 has three arms 804, with aninterconnecting member 110 attached to one each of the two arms 804 a,804 b with the third arm 804 c configured for direct attachment to bodytissue, for example via sutures. In one embodiment, the support body 802is fabricated from a porous mesh configured to be compatible withbiological in-situ tissue ingrowth.

In one embodiment, the arms 804 a, 804 b are provided with a first armsegment 810 extending from support body 802 and a second arm segment 812extending from the first arm segment 810, where the interconnectingmembers 110 extend from the second arm segment 812.

FIG. 15 is a top view of one embodiment of an implantable anatomicalsupport 900. The implantable anatomical support 900 is similar to theimplantable anatomical support 800 and includes the support body 802with the arms 804 extending from the support body 802, with oneadjustable anchor 120 slidably coupled to one interconnecting member 110and a fixed anchor 136 connected to another interconnecting members 110.During implantation, the surgeon selectively attaches the fixed anchor136 to appropriately identified tissue, attaches the adjustable anchorto adjacent tissue, and adjusts the adjustable anchor 120 along theinterconnection member 110 to suitably adjust the tension in the support900.

Although not illustrated in FIGS. 13-14, it is to be understood thatanchor 520 with tensioning element 530 (FIG. 6) could be utilized withanatomical support 700 and any number of combinations of anchor 520 withtensioning element 530 could also be utilized with or without any numberof fixed anchors 136.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

FIG. 16 is a top view of one embodiment of a system 1000 configured toaddress pelvic dysfunction in a patient. Pelvic dysfunction includesmale urinary incontinence, female urinary incontinence, or female pelvicorgan prolapse.

In one embodiment, the system 1000 is configured to address male urinaryincontinence and includes a support member 1002 and a tool 1004configured to couple with the anchors 120, 136 to implant the supportmember 1002 into the patient, for example via a single incision.

In one embodiment, the support member 1002 includes a body portion 1010,and opposing trans obturator arms 1012 and suprapubic arms 1014extending from the body portion 1010. In one embodiment, the fixedanchor 136 is attached to one of the trans obturator arms 1012 by theinterconnecting member 129 and the adjustable anchor 120 is attached tothe opposing one of the obturator arms 1012 by the interconnectingmember 110.

As described below, the tool 1004 is employed to attach/anchor theanchors 120, 136 into membrane material of the obturator foramen suchthat the obturator arms 1012 extend between the opposing obturatormembranes. The suprapubic arms 1014 are surgically placed suprapubically(with or without a tool).

In one embodiment, the anchor 120 is an adjustable anchor as describedabove and the support member 1002 includes four arms that are configuredfor four-point attachment to the patient to provide an adjustablesupport offering elevation and compression of the ventral urethral bulbof a man with compression of the perineal urethra. The support member1002, as implanted, is configured to provide immediate beneficial reliefto urinary incontinence and is also configured to allow tissue to growinto the porous structure of the support member 1002.

FIG. 17 is a top view of the support member 1002 modified to includeoptional suture lines 1015 connected to a removable tip 1017 at an endof each of the suprapubic arms 1014 and optional sleeves 1016 disposedover the arms 1014. The optional suture lines 1015 and sleeves 1016 areemployed when placing the arms 1014 suprapubically within the patientwith the tool 1004.

In general, the trans obturator arms 1012 are provided as a pair ofopposing and aligned arms and the suprapubic arms 1014 are not parallelwith the trans obturator arms 1012. Other conformations for supportmember 1002 are also acceptable, including more than four arms or fewerthan four arms, and the relative orientation between the arms providedin the examples is not intended to limit the scope of this application.

In one embodiment, the support member 1002 is fabricated from a porouspolypropylene mesh suited to allow tissue to grow into the mesh. In oneembodiment, the support member 1002 includes optional sleeves 1016disposed over the suprapubic arms 1014, for example, where the sleeves1016 reduce friction of the arms 1014 as they are implanted withintissue of the patient. In one embodiment, the optional suture lines 1015are braided polyester lines that are coated with a friction-reducingagent such as polytetrafluoroethylene, although other forms of suturelines and other forms of friction-reducing agents are also acceptable.

FIG. 18A is a top view of the tool 1004 and FIG. 18B is a close-up viewof a distal end portion 1026 of the tool 1004.

In one embodiment, the tool 1004 includes a hook 1020 extending from ahandle 1022 between a proximal end 1024 and a distal end portion 1026.The hook 1020 is a planar hook having a curve and is configured for aninside-out pass from a midline incision in the patient through amembrane tissue covering the obturator foramen. In one embodiment, thehook 1020 is formed of a suitable material, for example stainless steel,fashioned to lie in a plane (i.e., the hook 1020 is a “planar” hook)between the end 1024 and the distal end portion 1026. The illustratedembodiment of the hook 1020 in FIG. 18A is not a helical hook.

In one embodiment, the hook 1020 is a substantially solid hook (i.e.,the hook does not include a lumen) having a curved section 1027connected between a first linear section 1028 and a second linearsection 1629. The curvature of the curved section 1027 is not constantas the curved section 1027 has greater curvature adjacent the secondlinear section 1029 as compared to the first linear section 1028. Thesecond linear section 1029 is not parallel to the first linear section1028, and a ray extending from and aligned with the second linearsection will intersect a horizontal plane from which the proximal end1024 of the hook 1020 extends.

The hook 1020/tool 1004 is configured to implant the support member 1002into a male patient via an inside-out pass extending from a singleperineal incision to an obturator foramen of the male patient, where thepass minimizes the possibility of undesirably perforating the urethra orthe corpus cavernosa of the patient.

In one embodiment, the distal end portion 1026 of the hook 1020 (FIG.18B) includes a distal end 1030, an L-shaped slot 1032 proximal thedistal end 1030, and a T-shaped slot 1034 proximal the L-shaped slot.The hook 1020 is preferably formed from a stable material such asstainless steel and the handle 1022 is preferably formed from plastic,for example, although other materials are also acceptable.

FIG. 19 is a schematic view of a pelvis P of a patient having a pair ofobturator foramen OF. The pelvis P is surgically accessed through asingle, minimally invasive perineal incision 1040. A reference axis 1042is provided that is aligned on a midline of the patient's body from theincision 1040 through the pubic symphysis. The reference axis 1042separates the patient's body between the left side of the patient andthe right side of the patient (e.g., the right side includes theillustrated obturator foramen OF).

The support member 1002 (FIG. 17) is implanted, for example, by formingthe perineal incision 1040 and dissecting to isolate the bulbous urethra(for men) while ensuring that the bulbous spongiosis muscle remainsintact. The surgeon will optionally, depending upon surgeon preference,dissect down to the pubic ramus to identify this landmark.

With reference to FIGS. 17 and 18B, the surgeon forms the perinealincision 1040 and employs the tool 1004 to guide each of the transobturator arms 1012 along an inside-out path through the obturatorforamen. For example, a distal end 1030 of the hook 1020 is engaged withthe fixed anchor 136. The hook 1020 and the fixed anchor 136 areinserted into the perineal incision 1040, guided along an inside-outpath that extends inward to a descending portion of the ramus df thepatient, and into the membrane extending over the obturator foramen OF.The distal end 1030 of the hook 1020 penetrates the membrane extendingover the obturator foramen OF with an audible “pop,” indicating thefixed anchor 136 is attached to the membrane of the obturator foramenOF. In a similar maneuver, the distal end 1030 of the hook 1020 isengaged with the adjustable anchor 120, and the hook 1020 and adjustableanchor 120 are inserted into the perineal incision 1040, along acontra-lateral inside-out path to a descending portion of the ramus ofthe patient and into the membrane extending over the obturator foramenOF. Once again, when the distal end 1030 of the hook 1020 penetrates theforamen membrane an audible “pop” indicates a successful anchoring ofthe adjustable anchor 120 into the membrane of the obturator foramen.

In one embodiment, the suprapubic arms 1014 (having the optional sleeves1016 of FIG. 17 removed) are inserted into the single perineal incision1040 and tunneled into position subcutaneously within the patient. Forexample, the tool 1004 (or another suitable tool) is employed to insertthe suprapubic arms 1014 into the incision 1040 suprapubically, at whichlocation the arms 1014 are overlapped subcutaneously within the patientto allow tissue ingrowth to secure the support member 1002 within thepatient.

With reference to FIGS. 17 and 20, in one embodiment the suprapubic arms1014 (including the optional sleeves 1016 of FIG. 17) are implanted bythe tool 1004 subcutaneously within the patient via a pre-pubic opening.For example, the distal end 1030 of the hook 1020 is inserted under thepatient's skin and moved subcutaneously from the pre-pubic opening tothe perineal incision 1040 lateral the urethra. One of the suprapubicarms 1014 is attached to the T-shaped slot 1034 and retracted backwardsby the tool 1004 along the path from the perineal incision 1040 to thepre-pubic opening. The other suprapubic arm 1014 is implantedcontra-laterally in a similar manner. Afterwards, the suture, the tipand the optional sleeves 1016 are removed from the suprapubic arms 1014leaving the porous mesh in place for subsequent tissue ingrowth. In oneembodiment, excess length of the suprapubic arms 1014 is trimmed flushwith the patient's skin. In one embodiment, the suprapubic arms 1014 arecrossed/overlapped one over the other subcutaneously.

The trans obturator arms 1012 are suspended/connected in a midlinelocation between the membrane of the obturator foramen OF and thesuprapubic arms 1014 are retained in a fixed position subcutaneously. Inone embodiment, the interconnecting member 110 is pulled through theadjustable anchor 120 shorten the midline length between the ends of thetrans obturator arms 1012 and adjust tension in the support member 1002.In this manner, support member 1002 elevates and compresses the ventralurethral bulb B of the patient. The suprapubic arms 1014 are pulled toadjust tension prior to being secured to each other, which compressesthe perineal urethra U. The support member 1002 allows the surgeon totighten or loosen the tension between the arms 1012 by adjusting theadjustable anchor 120.

FIG. 21 is a schematic view of the support member 1002 implanted in amale patient. The illustration presents a sub-dermal view of thelocation of the support member 1002 relative to the ventral urethralbulb B of the patient. The trans obturator arms 1012 extend betweenmembranes covering the obturator foramen OF and are adjustable via theadjustable anchor 120 to elevate and compress the ventral urethral bulbB of the patient. The suprapubic arms 1014 are tunneled subcutaneouslyto compress the perineal urethra U. The surgeon adjusts thetension/elevation of the support member 1002 by drawing theinterconnecting member 110 through the adjustable anchor and adjusts thecompression of the support member 1002 against the ventral urethral bulbB of the patient by selectively tightening the suprapubic arms 1014.This adjustment of the two pairs of arms 1012, 1014 may be doneincrementally until the surgeon achieves the desired coaptation of theurethra U through the elevation and compression of the ventral urethralbulb B of the patient.

The implanted arms 1012, 1014 and the body portion 1010 allow tissueingrowth through the support member 1002, which tends to provide a moredurable and long-lasting support to address male incontinence.

The above-described approach to addressing urinary incontinence is lessinvasive than implanting an artificial urinary sphincter (artificialurinary sphincters can contribute to erosion of the urethra), which aidsthe patient to a faster recovery, and has the potential for immediatepost-implantation beneficial continence results.

The adjustable anchor 120 of the support member 1002 is movable alongthe interconnecting member 110 to adjust the elevation of a mid-area(identified as supporting the bulbous urethra B) of the support 1002relative to a urethra of the patient.

The elevation and compression of the urethra bulb provides VentralUrethral Elevation (VUE) that ensures consistent placement of thesupport with a decreased probability of loosening. The minimaldissection of the bulbous urethra minimizes the potential for distalmovement of the support member 1002. Support member 1002 is implantedthrough a single perineal incision 1040 that is less invasive than othersurgical interventions for remedying male incontinence.

FIG. 22A is a perspective view of one embodiment of a support member1100 including adjustable anchor 120 and a hanger 1102. In oneembodiment, the support member 1100 is a substantially rectangularporous mesh termed a “tape,” substantially as illustrated in FIG. 22A,and fabricated from materials similar to those described above for thesling 100 (FIG. 1). The support member 1100 is configured forimplantation into a male patient or a female patient via a singlemidline incision (perineal for men and paraurethral or vaginal forwomen) and includes a mechanism for adjusting tension in the support1100.

The adjustable anchor 120 described above is attached to the first end102 of the support member 1100 by the interconnecting member 110, and ahanger 1102 is attached to the second end 104 of the support member. Inone embodiment, the hanger 1102 is fabricated from plastic and isattached to the end 104 of the support 1100 by welding, stitching,adhesive attachment, or another suitable form of attachment.

The hanger 1102 is configured to hang over a portion of a pubic ramus ofa pelvis to secure a second end 104 of the support member 1100, and theadjustable anchor 120 is attachable to a membrane extending over anobturator foramen. The interconnecting member 110 slides relative to theanchor 120 to adjust the tension and support provided by the supportmember 1100. The hanger 1102 is configured to be placed over a surfaceof the pubic bone without the use of screws. In this manner, the hanger1102 does not penetrate the bone, which allows the surgeon to morequickly and accurately place the support 1100 inside the patient.

FIG. 22B is a side view and FIG. 22C is a front view of the hanger 1102.In one embodiment, the hanger 1102 extends between a proximal end 1110and a distal end 1112, and includes a curved hanging portion 1114. Theproximal end 1110 is attached to the end 104 of the support 1100 (FIG.22A). In one embodiment, the distal end 1112 converges to a point thatis configured to penetrate the obturator foramen membrane and allow thehanging portion 1114 to engage with and drape over a pubic ramus. Thehanging portion 1114 is curved to correspond to a curvature of the pubicramus bone of the pelvis.

FIG. 23 is a schematic view of the support member 1100 attached betweena pubic ramus PR of the pelvis P and tissue OT of the obturator foramenOF to support a urethra U of the patient. In one embodiment, the patientis a female and the support member 1100 supports the urethra U withoutcompressing the urethra U. In one embodiment, the patient is a male andthe support member 1100 supports the urethra U by elevating andcompressing at least a portion of a bulb the urethra U.

It is to be understood that it is undesirable to dissect tissue awayfrom and expose the urethra U (which can contribute to urethralerosion). The illustration of the figures shows a urethra U with athickness to indicate tissue is still surrounding the urethra.

In one embodiment, the hanger 1102 is introduced through a singleperineal incision 1140 along an inside out pass that places the hanger1102 around a portion of the pubic ramus PR. For example, the surgeonplaces the hanger 1102 either digitally with a finger, or with a tool,into the incision 1140 and guides the hanger 1102 inward against themembrane covering the obturator foramen, after which the surgeonpenetrates the membrane with the pointed distal end 1112 (FIG. 22C) ofthe hanger 1102. Movement of the pointed distal end 1112 of the hanger1102 through the obturator foramen membrane positions the hangingportion 1114 for engagement over the pubic ramus PR.

The adjustable anchor 120 is guided through the incision 1140 with thetool 1004 (FIG. 18A) as described above in FIG. 19. The tension of thesupport member 1100 is adjusted by pulling on the interconnecting member110 until a desired length of the support member 1100 is achieved thatprovides support to the tissue around the urethra U, as described above.In this manner, the adjustable anchor 120 of the support 1100 allows theelevation of mid-area of the support 1100 under the urethra to beadjusted to support the urethra without displacing or compressing theurethra (as desirable in a female). The surgeon closes the minimallyinvasive single incision 1140 according to acceptable practices. Thesupport provides the patient with a state of continence immediatelyafter implantation due to the support or support and elevation of theurethra U.

FIG. 24 is a top view of one embodiment of a support member 1200including adjustable anchors 120 and adjustable hangers 1102 that allowthe support 1200 to be implantable via a single incision. The supportmember 1200 is similar to the support member 1002 (FIG. 17) and includesthe body portion 1010, and opposing trans obturator arms 1012 andsuprapubic arms 1014 extending from the body portion 1010.

In one embodiment, an adjustable anchor 120 is attached to each of theopposing trans obturator arms 1012 by an interconnecting member 110, andthe adjustable hanger 1102 is attached to each of the suprapubic arms1014 by an adjustable suture 1202. The adjustable suture 1202 isconfigured to allow the independent adjustment of the distance betweeneach hanger 1102 and the arm 1014 to which it is attached in a mannersimilar to that described above in FIGS. 2-4, for example. For example,the adjustable hanger 1102 is movable distally and proximally along thesuture line 1202 to allow for the selected and independent adjustment ofthe hanger 1102 relative to the support 1200. The support member 1200 isconfigured for implantation into the patient via a single incision, andas such, the optional sleeves 1016 (FIG. 17) covering one or more of thearms are not provided on the support member 1200.

The support member 1200 is fabricated from the materials describedabove, and in one embodiment is provided as a porous polypropylene meshhaving a pore size of about 665 micrometers, a porous area of about42.3% of the total area, a basis weight of about 119 g/m², and athinness of about 635 micrometers.

The adjustable anchors 120 and hangers 1102 are as described above. Itis to be understood that the support 1200 could be provided with fouradjustable anchors 120 or four adjustable hangers 1102, or combinationsof adjustable anchors and hangers. During implantation, the surgeonselectively and independently adjusts each anchor 120 and each hanger1102 by sliding the adjustable component along its respective line 110,1202 to achieve the desired amount of support or elevation orcompression of the implanted support 1200 relative to the patient'sanatomy.

FIG. 25 is a schematic view of one embodiment of the support member 1200having the adjustable anchors 120 attached to membranes of obturatorforamen OF and the hangers thousand 102 secured to the pelvis P.

In one embodiment, support member 1200 is implanted into the pelvis ofthe patient through a single midline incision 1240. In a male example,the adjustable anchors 120 are implanted through a perineal incision ofa man and attached to the membrane tissue OT extending over theobturator foramen OF by the tool 1004 (FIG. 16) via the approachdescribed above. In a female example, the adjustable anchors 120 areimplanted through a vaginal incision of a woman and attached to themembrane tissue OT extending over the obturator foramen OF by the tool1004 (FIG. 16) via the approach described above.

In particular, one of the adjustable anchors 120 is attached to thedistal end 1030 of the tool 1004, the distal end 1030 and the adjustableanchor 120 are inserted through the incision 1240 and guided to alocation superior the pubic ramus PR where the tool 1004 forces theadjustable anchor 120 into the membrane OT of the obturator foramen OFto attach one of the trans obturator arms 1012 to the patient. A similarmaneuver is carried out on the contra-lateral side of the patient toimplant the other of the trans obturator arms 1012.

In one embodiment, suprapubic arms 1014 are each inserted individuallyand guided suprapubically and subcutaneously to a prominence of thepelvis P over which the anchors 1102 are hung. The suture line 1202 isadjusted to place the arm 1014 in the desired location. Alternatively, atool or other device is employed to guide the hangers 1102subcutaneously to the pelvis P.

The anchors 120 are adjusted to support to the urethra U by sliding one(or both) of the interconnecting members 110 through a respective one ofthe adjustable anchor 120 after implantation of the support member 1200in the manner described above. In this manner, tension provided by thesupport member 1200 relative to the urethra U is adjustable by thesurgeon to achieve compression and elevation of the urethra U in a manor support without compression of the urethra in a woman. Each of theadjustable anchors 120 is individually adjustable to allow the urethra Uto be centered relative to the trans obturator arms 1012.

FIG. 26 is a schematic view of a pair of adjustable slings 100 asillustrated in FIG. 1 implanted into a patient via a single incision1140 to alleviate pelvic dysfunction.

In one embodiment, two or more slings 100 are implanted into a malepatient through a single minimally invasive perineal incision 1140 (forexample with tool 1004) and held in place by anchors 120, 136. Theadjustable anchor 120 permits each sling 100 to be adjusted. Inaddition, each sling 100 is configured to be selectively positioned bythe surgeon to provide elevation and compression of the urethral bulbaround the urethra U of a male patient.

In one embodiment, two or more slings 100 are implanted into a femalepatient through a single minimally invasive vaginal incision 1140(again, with the tool 1004) and held in place by the anchors 120, 136.The adjustable anchor 120 permits each sling 100 to be adjusted. Thesurgeon may selectively position each sling 100 to provide support forthe urethra of the female without compression of the urethra, which canundesirably erode the short female urethra.

By the embodiments described above, adjustable slings and supports areprovided that are configured to be implanted into the patient (male orfemale) through one minimally invasive single incision. The adjustablesupport provides an immediate remedy to the incontinence of the patientbecause of the tensioned and adjustable arms in combination with therapid healing of the minimally invasive procedure.

It is to be again appreciated that components of these devices could bereversed, if desired, in a right side/left side sense from theirarrangements as shown in the examples of FIGS. 1 and 5. It is also to beappreciated that method steps could be performed in other sequences.

It is also to be appreciated that the examples of methods describedherein, for surgical placement of devices for anatomical support, do notrequire skin exits or incisions other than for a single vaginal incision(or, in a male patient, a single perineal incision) for placement andadjustment.

Upon occurrence of tissue in-growth, after implantation surgery iscompleted and during the patient's healing process, anchors might thenbecome unnecessary to continue to secure the anatomical support devicein the patient. Therefore, any of the anchors and the interconnectingmembers could be made of a suitable medical grade bioresorbablematerial.

It is to be also appreciated that the foregoing examples of implantabledevices for anatomical support provide means for adjustment ortensioning of anatomical support members that are not dependent uponanchor placement. For example, increased tensioning of the devices maybe advantageously achieved without a need for advancing anchors moredeeply into target tissue in the patient. Also, the aforedescribedfrictional sliding engagement between interconnecting member 110 andadjustable anchor 120—or between interconnecting member 110 andtensioning element 530—permits novel intra-operative adjustment of theimplantable devices for anatomical support disclosed herein. Furthermoreadjustable anchor 120, as well as the combination of anchor 520 withtensioning element 530, permits such intra-operative adjustment to beperformed as many times as desired during a particular implantationprocedure, to achieve optimal device placement, adjustment, andtensioning.

While implantable devices, tools, and methods for anatomical supporthave been particularly shown and described herein with reference to theaccompanying specification and drawings, it will be understood howeverthat other modifications thereto are of course possible; and all ofwhich are intended to be within the true spirit and scope of the claimedinvention. It should be appreciated that (i) components, dimensions,shapes, and other particulars of the example embodiments herein may besubstituted for others that are suitable for achieving desired results,(ii) various additions or deletions may be made thereto, and (iii)features of the foregoing examples may also be made in combinationsthereof. It is also to be understood in general that any suitablealternatives may be employed to provide these implantable devices,tools, and methods for anatomical support.

Lastly, choices of compositions, sizes, and strengths of variousaforementioned elements, components, and steps all depend upon intendeduses thereof. Accordingly, these and other various changes ormodifications in form and detail may also be made, again withoutdeparting from the true spirit and scope of the invention as defined bythe appended claims.

What is claimed is:
 1. A urinary incontinence device comprising: asupport having a first end and a second end; a hanger attached to thefirst end, the hanger comprising a segment that is curved and soconfigured to hang over a surface of a pubic bone; an interconnectingmember attached to the second end; and an anchor movably engaged withthe interconnecting member, the anchor implantable into tissue of anobturator foramen of a patient, the anchor comprising a body and acollar received over the body, the collar having a first aperture and asecond aperture and the anchor defining a pathway in a space between thebody and the collar that extends from the first aperture to the secondaperture of the collar, the interconnecting member being receivedthrough the first and second apertures such that a portion of theinterconnecting member is compressed between the body and the collar,that portion of the interconnecting member compressed between the collarand the body extending from the first aperture to the second apertureand extending around a partial circumference of the body; wherein theinterconnecting member is movable relative to the implanted anchor toadjust an elevation of the support relative to a urethra of the patient,upon application of a sufficient force to overcome frictionalinterference between the implanted anchor and the interconnectingmember.
 2. The urinary incontinence device of claim 1, wherein thesupport is a tape having two opposed trans obturator arms.
 3. Theurinary incontinence device of claim 1, wherein the support includes atrans obturator arm and a suprapubic arm.
 4. The urinary incontinencedevice of claim 3, wherein the interconnecting member is attached to thetrans obturator arm and the hanger is attached to an end of thesuprapubic arm.
 5. The urinary incontinence device of claim 1, whereinthe hanger comprises an adjustable hanger that is attached to the firstend of the support by a suture line, the adjustable hanger configured tomove distally and proximally along the suture line.
 6. The urinaryincontinence device of claim 1, wherein the anchor includes a bodyhaving a proximal end and a distal end with a channel extendinglongitudinally through the body along a longitudinal axis of the body,and a plurality of flanges protruding radially outward from thelongitudinal axis of the body proximate the distal end of the body, theflanges being configured to be more easily compressed inwardly towardthe longitudinal axis of the body than flexed outwardly away from thelongitudinal axis of the body when the flanges are in a relaxed state,each of the plurality of flanges of the first anchor being separatedfrom an adjacent one of the plurality of flanges by a web of material,the web of material resisting flexing of the flanges outwardly away fromthe body when the flanges are in a relaxed state.
 7. A urinaryincontinence device comprising: a support having a first end portion, asecond end portion, and a support portion between the first and secondend portions; an interconnecting member coupled to the first endportion; and a first anchor receiving the interconnecting member, thefirst anchor including a body having a proximal end and a distal endwith a channel extending longitudinally through the body along alongitudinal axis of the body, and a plurality of flanges protrudingradially outward from the longitudinal axis of the body proximate thedistal end of the body, the flanges being configured to be more easilycompressed inwardly toward the longitudinal axis of the body than flexedoutwardly away from the longitudinal axis of the body when the flangesare in a relaxed state, each of the plurality of flanges of the firstanchor being separated from an adjacent one of the plurality of flangesby a web of material, the web of material resisting flexing of theflanges outwardly away from the body when the flanges are in a relaxedstate, wherein the first anchor further comprises a collar received overthe body of the first anchor, the collar having a first aperture and asecond aperture and the first anchor defining a pathway in a spacebetween the body and the collar that extends from the first aperture tothe second aperture of the collar, the interconnecting member beingreceived through the first and second apertures such that a portion ofthe interconnecting member is compressed between the collar and thebody, that portion extending from the first aperture to the secondaperture and extending around a partial circumference of the body.
 8. Aurinary incontinence device comprising: a support having a first end anda second end; an interconnecting member attached to the second end; andan anchor movably engaged with the interconnecting member, the anchorimplantable into soft tissue for anchoring the support beneath theurethra, the anchor comprising a body and a collar received over thebody, the collar having a first aperture and a second aperture and theanchor defining a pathway in a space between the body and the collarthat extends from the first aperture to the second aperture of thecollar, the interconnecting member being received through the first andsecond apertures such that a portion of the interconnecting member iscompressed between the collar and the body, that portion of theinterconnecting member compressed between the collar and the bodyextending from the first aperture to the second aperture and extendingaround a partial circumference of the body, the anchor being movablerelative to the implanted anchor to adjust an elevation of the supportrelative to a urethra of the patient upon application of a sufficientforce to overcome frictional interference on the portion of theinterconnecting member compressed between the body and the collar.